Collaboration Oriented Approach to Controlling High Blood Pressure

NCT06124716 | Active Not Recruiting DMC

• 1 other identifier: R18HS028579
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 3

Brief Summary

Hypertension is a significant contributor to poor cardiovascular outcomes. Self-management support tools can increase patient behaviors to improve blood pressure. The investigators created a clinical decision support app, called COACH, to integrate home blood pressure data and goals into EHR reporting and workflow with communications informed by behavioral economics principles to support shared decision-making. The study aims to measure the effectiveness of the COACH intervention in a pragmatic multi-site randomized trial in a primary care setting.

Conditions

Hypertension; Multiple Chronic Conditions

Keywords

Pragmatic trial; Primary care; Clinical decision support

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Control

  Percent of participants at or below 140/90 (office BP) or 135/85 (home BP) average.

  Up to 6 months

Secondary Outcomes (4)

• Reduction in Systolic and/or Diastolic Blood Pressure

  Up to 6 months

• Demographic factors contributing to blood pressure control

  Up to 6 months

• COACH Application System Usability Evaluation

  Up to 6 months

• Participant report of health behaviors including Self Efficacy, Social Support, Outcome Expectations and Self-regulation

  2 months, 6 months

Study Arms (2)

Enhanced COACH

EXPERIMENTAL

Enhanced blood pressure management recommendations that use cognitive and behavioral science to increase the likelihood of self-management goal setting to lower blood pressure. The CDS tool allows participant access to BP visualizations, reminders, and affectively tailored messaging about blood pressure management.

Other: Enhanced COACH CDS Tool

Usual Care COACH

ACTIVE COMPARATOR

Equivalent of usual care delivered through the CDS tool: Blood pressure management with basic information, reduced reminders, and no affective alerts.

Other: Usual Care COACH CDS Tool

Interventions

Enhanced COACH CDS Tool OTHER

CDS tool with features to promote high blood pressure management

Enhanced COACH

Usual Care COACH CDS Tool OTHER

CDS tool with limited features to promote high blood pressure management

Usual Care COACH

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-100 years old
• Patient receives care at a participating primary care clinic and has been seen in the last year
• Patient has high BP, defined as an average of 4 BPs \> 140 systolic or \> 90 diastolic (clinic) or \> 135 OR \> 85 (home)
• Patient is enrolled in online health portal
• Patient can communicate in English
• Patient has been recommended by their physician who thinks the patient would benefit from a home blood pressure monitoring program.

You may not qualify if:

• Patient is pregnant at the time of consent
• Patient who, in the opinion of the primary care clinician, has severe cognitive impairment
• Patient is on hospice care and/or has a life expectancy of less than 2 years
• Patient has end stage renal disease
• Patient for whom tight blood pressure control presents a greater risk, such as those with a history of adverse events from hypertension treatment (falls, dizziness, electrolyte disturbances, hypotension, active heart failure)
• Patient has any other disease or disorder that in the opinion of the investigator or the patient's primary care clinician, could put participants at risk and affect trial results, or hinder participation will exclude them from participating

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Missouri-Columbia: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (3)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Dorr DA, Montgomery E, Ghumman AJ, Michaels L, Rolbiecki A, Canfield S, Shaffer V, Johnson B, Lockwood M, Ghosh P, Martinez W, Koopman R; COACH Consortium. Study protocol: Collaboration Oriented Approach to Controlling High blood pressure (COACH) in adults - a randomised controlled trial. BMJ Open. 2024 Jul 8;14(7):e085898. doi: 10.1136/bmjopen-2024-085898.

  PMID: 38977368 DERIVED

MeSH Terms

Conditions

Hypertension; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Dorr, MD, MS, FACMI, FAMIA

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Richelle Koopman, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Statisticians and investigators will be blinded to allocation status. Study participants will be informed that the study is testing the effectiveness of a home BP monitoring program, but not that the study is comparing two models of care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mixed methods design with qualitative RE-AIM inquiry nested within a pragmatic multi-site randomized trial

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: January 12, 2024
• Primary Completion: May 31, 2026
• Study Completion: June 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (3)